MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Improper Device Output (2953)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Electric Shock (2554)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

The patient was getting jolted and shocked earlier today and could not turn the stimulation off.Overstimulation from the waist down was noted.The patient was crying about the event.The patient eventually was able to turn the implant off.It was wondered if the system was broken or if it was something the patient did.The patient declined to be seen at her doctor¿s office to have the ins interrogated.The surgical dressings were still present from implant yesterday.It was recommended to the patient to go into the patient programmer (pp) and turn all 3 programs to 0, leave the stimulation off for 24 hours and start over tomorrow.The patient was reminded to be aware of her positions and the need to adjust appropriately until the sensor can be activated in approximately 4 weeks.The company representative reported on (b)(6) 2014 that they saw the patient on (b)(6) 2014 and she was feeling much better with her stimulation system.A ¿good recharge¿ was noted.The patient had good coverage except for the hips.There was still some genital stimulation but was able to be managed for now with amplitude adjustments.

Manufacturer Narrative

Product id: 977a260, serial# (b)(4), product type: lead.Product id: 97740, serial# (b)(4), product type: programmer.Patient product id: 977a260, serial# (b)(4), product type: lead.Product id: 97754, serial# (b)(4), product type: recharger.

Event Description

Additional information received fifteen days later reported that the patient had effective pain relief in low back and legs.It was noted that there was no effective relief in the hips which were not covered in the trial.If additional information is received, a supplemental report will be filed.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3676863
• MDR Text Key: 4255128
• Report Number: 3004209178-2014-04379
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2014
• Date Device Manufactured: 11/25/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00065 YR